Human Research Protection Programs (HRPP)

The core concept of a HRPP is to engage all stakeholders in ensuring the protection of human subjects in research. With increasing reliance on external IRBs, a highly functioning HRPP has become even more essential to ensure that organizations fulfill their responsibilities to oversee research, protect local subjects, and support regulatory compliance and best practices.

HRP Consulting can provide expert assistance with practically any aspect of HRPP evaluation, development, or management, including the following:

• Program Evaluation
• Process Assessments/Mapping
• Establishing or Refining a HRPP
• Accreditation Support
• Policies and Procedures, associated materials
• IRB Evaluation and Support
• IRB or Investigator Audits
• Training and Education
• Interactions with or Responding to Federal Agencies
• Temporary Staff
• On-call guidance and support

Institutional Review Board (IRB)

Our roots are in human research protections and IRB. HRP Consulting can provide expert assistance with practically any aspect of IRB development and management, including the following:

• Setting Up an IRB or Ethics Committee
• IRB Reliance Management
• IRB Process Evaluation and Enhancement
• IRB Compliance Evaluations
• Policies, Procedures, Forms and Checklists
• Training and Education
• IRB Review Consultations
• Temporary IRB Members
• Temporary IRB Staff
• On-call guidance and support

Institutional Animal Care and Use Committee (IACUC)

HRP Consulting can also provide expert assistance with practically any aspect of IACUC development, operations and management, including the following:

• Setting Up an IACUC
• IACUC Process Evaluation and Enhancement
• IACUC PHS and USDA Compliance Evaluations
• IACUC Policies, Procedures, Forms and Checklists
• General and Species-specific Training and Education
• Assistance in Conducting IACUC Semi-Annual Program and Facility Evaluations
• Providing Temporary IACUC Members
• Providing Temporary IACUC Staff

Research Administration/Operations

HRP Consulting can provide expert guidance on the many aspects of research operations. Conducting research properly can be complicated. With HRP’s extensive experience on both the regulatory/compliance side of research, and the operations/administration of research, HRP can help your organization in many areas of research operations, including, but not limited to, the following:

• Research Contract Review/Negotiations (CTA, CDA/NDA, Master Agreements, etc.)
• Identify appropriate staffing models for research coordinators/staff
• Assistance with Acuity Scoring to measure workload
• Assessment of current research organizational infrastructure
• Identifying methods and processes to increase participant recruitment
• Identifying gaps in research billing compliance

Other Research Compliance

HRP Consulting prides itself on its wide network of consultants and professional associates with experience in multiple aspects of research oversight and compliance, including, but not limited to, the following:

• HIPAA
• Biosafety
• International/Transnational Research
• Conflicts of Interest (COI)
• Reporting to Federal Agencies
• Research Misconduct
• Compliance Assessments/Audits
• Noncompliance
• CAPA Development
• Training (e.g., Investigator Responsibilities, Device Determinations, etc.)